Nutrineal PD4 with 1.1% amino acids

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

CALCIUM CHLORIDE, DIHYDRATE, PHENYLALANINE, HISTIDINE, ARGININE, THREONINE, TRYPTOPHAN, TYROSINE, VALINE, GLYCINE, METHIONINE, ISOLEUCINE, LYSINE HYDROCHLORIDE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SERINE, PROLINE, SODIUM CHLORIDE, SODIUM LACTATE

Disponible depuis:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

Code ATC:

B05DB

DCI (Dénomination commune internationale):

TRYPTOPHAN 270 mg/l CALCIUM CHLORIDE DIHYDRATE 184 mg/l ARGININE 1071 mg/l ALANINE 951 mg/l PHENYLALANINE 570 mg/l HISTIDINE 714 mg/l THREONINE 646 mg/l GLYCINE 510 mg/l METHIONINE 850 mg/l ISOLEUCINE 850 mg/l LYSINE HYDROCHLORIDE 955 mg/l MAGNESIUM CHLORIDE HEXAHYDRATE 51 mg/l SERINE 510 mg/l LEUCINE 1020 mg/l PROLINE 595 mg/l SODIUM CHLORIDE 5380 mg/l SODIUM LACTATE 4480 mg/l TYROSINE 300 mg/l VALINE 1393 mg/l

forme pharmaceutique:

SOLUTION FOR PERITONEAL DIALYSIS

Composition:

TRYPTOPHAN 270 mg/l CALCIUM CHLORIDE DIHYDRATE 184 mg/l ARGININE 1071 mg/l ALANINE 951 mg/l PHENYLALANINE 570 mg/l HISTIDINE 714 mg/l THREONINE 646 mg/l GLYCINE 510 mg/l METHIONINE 850 mg/l ISOLEUCINE 850 mg/l LYSINE HYDROCHLORIDE 955 mg/l MAGNESIUM CHLORIDE HEXAHYDRATE 51 mg/l SERINE 510 mg/l LEUCINE 1020 mg/l PROLINE 595 mg/l SODIUM CHLORIDE 5380 mg/l SODIUM LACTATE 4480 mg/l TYROSINE 300 mg/l VALINE 1393 mg/l

Type d'ordonnance:

POM

Domaine thérapeutique:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Statut de autorisation:

Authorised

Date de l'autorisation:

2005-12-29

Notice patient

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NUTRINEAL PD4 1.1% AMINO ACIDS,
SOLUTION FOR PERITONEAL DIALYSIS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet.
WHAT IS IN THIS LEAFLET
1.
What Nutrineal
is and what it is used for
2.
What you need to know before you use Nutrineal
3.
How to use Nutrineal
4.
Possible side effects
5.
How to store Nutrineal
6.
Contents of the pack and other information
1.
WHAT
NUTRINEAL
IS AND WHAT IT IS USED FOR
Nutrineal
is a solution for peritoneal dialysis which does not contain glucose.
It removes water and waste
products from the blood and corrects different abnormal components of
blood.
Nutrineal
may be prescribed for you :
•
if you have kidney failure which needs peritoneal dialysis
•
in particular if you are malnourished.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRINEAL
Your doctor will assess whether Nutrineal is a suitable solution for
your peritoneal dialysis treatment. He
will have taken into account any factors in your medical history which
might exclude the use of peritoneal
dialysis solutions.
DO NOT USE
NUTRINEAL
You must NOT use Nutrineal
•
If you are allergic to any amino acids or any of the other ingredients
of this medicine (listed in section
6).
•
If your blood urea level is above 38 mmol/l.
•
If you suffer from a disorder affecting amino acid metabolism.
•
If your blood potassium level is too low.
•
If you show uraemic symptoms such as loss of appetite, nausea or
vomiting.
•
If your blood bicarbonate levels are too low.
•
If you suffer from liver insufficiency.
•
If you already have severe lactic acidosis (too much acid in the
blood)
•
If
you
have
a
surgically
uncorrectable
problem
affecting
your
abdominal
wall
or
cavity
or
uncorrectable problem th

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Nutrineal PD4 with 1.1% amino acids.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
L-Tyrosine
300 mg/l
L-Tryptophan
270 mg/l
L-Phenylalanine
570 mg/l
L-Threonine
646 mg/l
L-Serine
510 mg/l
L-Proline
595 mg/l
Glycine
510 mg/l
L-Alanine
951 mg/l
L-Valine
1393 mg/l
L-Methionine
850 mg/l
L-Isoleucine
850 mg/l
L-Leucine
1020 mg/l
L-Lysine hydrochloride
955 mg/l
L-Histidine
714 mg/l
L-Arginine
1071 mg/l
Calcium chloride dihydrate
184 mg/l
Magnesium chloride hexahydrate
51 mg/l
Sodium S-Lactate
4480 mg/l
Sodium Chloride
5380 mg/l
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Peritoneal Dialysis
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Nutrineal is recommended as a non-glucose based peritoneal dialysis
solution as part of a
peritoneal dialysis regimen for the treatment of chronic renal failure
patients. In particular, it is
recommended for the malnourished peritoneal dialysis patients.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
ADMINISTRATION
Nutrineal is intended for intraperitoneal administration only. Not for
intravenous
administration.
Peritoneal dialysis solutions may be warmed in the overpouch to 37°C
to enhance patient
comfort. However, only dry heat (for example, heating pad, warming
plate) should be used.
Solutions should not be heated in water due to an increased risk of
contamination. Solutions
should not be heated in a microwave oven due to the potential for
damage to the solutions
container and patient injury or discomfort.
Aseptic technique should be employed throughout the peritoneal
dialysis procedure.
Do not administer if the solution is discoloured, cloudy, contains
particulate matter or shows
evidence of leakage, or if seals are not intact.
The drained fluid should be inspected for the presence of fibrin or
cloudiness, which may
indicate the presence of peritonitis.
For single use only.
POSOLOGY
The mode of therapy, frequency of treatment, exchange volume, duration
of dwell and length